On this page

Crofab

Crotalidae Polyvalent Immune Fab (Ovine)

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Crofab

Proper name

Crotalidae Polyvalent Immune Fab (Ovine)

Licence type

351(a)

BLA number

103788

Applicant

BTG International Inc.

Center

CBER

Presentations

First licensure

—

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
1G	For Injection	Intravenous	Single-Dose Vial	Rx	October 2, 2000

Source: Purple Book

Kind	Expires
Orphan exclusivity	October 2, 2007

Purple Book	FDA	Licence type, presentations, reference product, exclusivity